Homeopathic Study Based On Modern Scientific Methodology

[n***@gmail.com]

First Ever Homeopathic Study Based On Modern Scientific Methodology Published
in AMA Journal
8/13/98 --VERTIGOHEEL(R) Shown to be Safe and Effective in the Treatment of
Vertigo
A study published in the August issue of the American Medical
Association Journal Archives of Otolaryngology - Head and Neck Surgery shows
that VERTIGOHEEL(R), a prescription homeopathic medication, is as effective and
safe as betahistine, a histamine analogue considered standard therapy in Europe
for the management of vertigo symptoms. 
The publication of this study in an AMA journal reflects the growing
interest in homeopathic medicine. In fact, in the July 15, 1998 issue of the
Journal of the American Medical Association (JAMA), a survey of readers
identified "alternative medicine" such as homeopathy, as one of the top ten
topics of which more information should be published.
Vestibular or balance disorders such as vertigo, dizziness, and motion
sickness affect approximately two million people in the U.S. Despite the
severity of vertigo, American physicians lack a conventional medication proven
to be an effective treatment for the disease. This study represents the first
equivalence trial comparing a homeopathic treatment for vertigo to standard
drug therapy. 
"This is the first time that the AMA has published a study of a
homeopathic drug - a study that was designed according to modern
scientific methodology," said Dana Ullman, MPH, president of the
Foundation for Homeopathic Education and Research, and author of
numerous books on homeopathy. "Other respected, peer-reviewed medical
publications such as The Lancet, Pediatrics and British Medical Journal are now
joined by the AMA's Archives of Otolaryngology in their scientific review of
homeopathic studies."
The year-long, double-blind, randomized, controlled clinical trial
compared the efficacy and safety of VERTIGOHEEL(R) with betahistine. The study
included 119 male and female patients with acute or chronic vertigo symptoms of
various origins. The clinical trial was conducted from 1995 to 1996 at 15
medical clinics throughout Germany. 
In accordance with good clinical practices, patients were assigned to
one of two treatment groups: the VERTIGOHEEL(R) group or the betahistine group.
Patients in both groups were given 15 drops three times per day of the active
drug (VERTIGOHEEL(R) or betahistine) for 42 consecutive days.
Study Results
The primary efficacy variables for the study were the frequency,
duration, and intensity of vertigo attacks. After six weeks,
vertigo-specific complaints were significantly reduced in both treatment
groups. VERTIGOHEEL(R) and betahistine were therapeutically equivalent in
reducing the duration and intensity of vertigo attacks. Although not clinically
significant, VERTIGOHEEL(R) was marginally superior to betahistine in reducing
the frequency of vertigo attacks.
The study's secondary efficacy variables involved quality of life
measurements, including physical health and mental activity, from the patients'
point of view. These were assessed using the standardized MOS-SF36 validated
quality of life questionnaire as well as a four-part vertigo-specific
questionnaire. The patients' and investigators' global assessment of efficacy
also comprised the study's secondary efficacy variables. 
There was an increase in the patients' quality of life and a significant
decrease in vertigo-specific symptoms in both treatment groups.
According to investigators, more than 70 percent of patients in both of the
VERTIGOHEEL(R) and betahistine groups reported a significant
improvement in quality of life. In addition, for more than 90 percent of study
patients in both treatment groups, the tolerability of both drugs was rated as
"good" or "excellent."
Clinical laboratory data and vital signs for each patient remained
essentially unchanged throughout the course of the study, indicating a
favorable safety profile for both VERTIGOHEEL(R) and betahistine.
"These results establish VERTIGOHEEL(R) as a safe and effective
treatment for vertigo," said study investigator Michael Weiser, PhD,
Director of Clinical Research, Heel, GmbH. "VERTIGOHEEL(R) was shown to be as
effective as betahistine, a standard anti-vertigo drug, in significantly
reducing the frequency and severity of vertigo attacks, and was also very
well-tolerated. Because of the lack of effective conventional treatments,
VERTIGOHEEL(R) fills a serious void for treating millions of Americans
suffering from vertigo and other types of dizziness." 
"We are excited about the publication of this head-to-head clinical
comparison in an American Medical Association (AMA) journal," said Perry
Pedersen, Vice President, General Manager, Heel Inc., the U.S.
manufacturer and exclusive distributor of VERTIGOHEEL(R). "Not only does it
prove that VERTIGOHEEL(R) is an effective and safe drug for treating vertigo,
but it also demonstrates why homeopathic drugs are gaining acceptance among
patients and medical practitioners throughout the world. The fact that such a
study has been published in an AMA journal is a landmark in itself. The
clinical utility of homeopathic drugs like VERTIGOHEEL(R) is now being
objectively assessed by our most respected medical institutions."
About Vertigo
Vertigo is a condition where sufferers experience a false sensation of
motion - either horizontally or vertically. It is a disorder of the
body's vestibular system, which is located in the inner ear and
responsible for maintaining equilibrium. Although manyof the causes of vertigo
are unknown, the most common causes include head trauma or whiplash, migraine,
advanced age, ear infections, viruses, high doses or long-term use of certain
antibiotics, stress and fatigue, and stroke or conditions resulting in reduced
blood flow to the inner ear or brain. Vestibular disorders, which also include
motion sicknesses (e.g., car sickness and sea sickness), are among the most
common reasons for doctor visits, with U.S. physicians reporting more than five
million related visits per year.
About Heel Inc.
VERTIGOHEEL(R) is manufactured and distributed in the U.S. by Heel Inc., a
marketer and manufacturer of combination homeopathic remedies based in
Albuquerque, NM. Heel Inc. is also the U.S. distributor for its parent company,
Heel GmbH in Baden-Baden, Germany, the world's largest manufacturer and
marketer of combination homeopathic pharmaceuticals, distributing products in
over 55 countries. Heel Inc. manufactures and markets over-the-counter (OTC)
and prescription pharmaceuticals (including injectables) according to the
regulatory requirements for homeopathic drugs as defined in the 1938 Food, Drug
and Cosmetic Act, the FDA's 1988 Compliance Policy Guides - Conditions Under
Which Homeopathic Drugs May be Marketed, the Homeopathic Pharmacopoeia
Convention of United States (HPCUS), and local health agencies (e.g., the New
Mexico State Board of Pharmacy). 
Unlike classical homeopathic drugs, the active ingredients in products
such as VERTIGOHEEL(R) are not ultra-highly diluted and the
pharmacological and clinical profiles can be defined within the
conventional medical paradigm. The products of Heel Inc. represent a
bridge between classical homeopathy and conventional pharmacology.
For full prescribing information about VERTIGOHEEL (R), please see page 1187 of
the 1998 Physicians' Desk Reference.
CONTACT: Heel Inc.
Perry Pedersen, 505/293-3843
or MCS Public Relations
Olga Silva, 908/273-9626

[n***@gmail.com]

First Ever Homeopathic Study Based On Modern Scientific Methodology Published
in AMA Journal
8/13/98 --VERTIGOHEEL(R) Shown to be Safe and Effective in the Treatment of
Vertigo
A study published in the August issue of the American Medical
Association Journal Archives of Otolaryngology - Head and Neck Surgery shows
that VERTIGOHEEL(R), a prescription homeopathic medication, is as effective and
safe as betahistine, a histamine analogue considered standard therapy in Europe
for the management of vertigo symptoms. 
The publication of this study in an AMA journal reflects the growing
interest in homeopathic medicine. In fact, in the July 15, 1998 issue of the
Journal of the American Medical Association (JAMA), a survey of readers
identified "alternative medicine" such as homeopathy, as one of the top ten
topics of which more information should be published.
Vestibular or balance disorders such as vertigo, dizziness, and motion
sickness affect approximately two million people in the U.S. Despite the
severity of vertigo, American physicians lack a conventional medication proven
to be an effective treatment for the disease. This study represents the first
equivalence trial comparing a homeopathic treatment for vertigo to standard
drug therapy. 
"This is the first time that the AMA has published a study of a
homeopathic drug - a study that was designed according to modern
scientific methodology," said Dana Ullman, MPH, president of the
Foundation for Homeopathic Education and Research, and author of
numerous books on homeopathy. "Other respected, peer-reviewed medical
publications such as The Lancet, Pediatrics and British Medical Journal are now
joined by the AMA's Archives of Otolaryngology in their scientific review of
homeopathic studies."
The year-long, double-blind, randomized, controlled clinical trial
compared the efficacy and safety of VERTIGOHEEL(R) with betahistine. The study
included 119 male and female patients with acute or chronic vertigo symptoms of
various origins. The clinical trial was conducted from 1995 to 1996 at 15
medical clinics throughout Germany. 
In accordance with good clinical practices, patients were assigned to
one of two treatment groups: the VERTIGOHEEL(R) group or the betahistine group.
Patients in both groups were given 15 drops three times per day of the active
drug (VERTIGOHEEL(R) or betahistine) for 42 consecutive days.
Study Results
The primary efficacy variables for the study were the frequency,
duration, and intensity of vertigo attacks. After six weeks,
vertigo-specific complaints were significantly reduced in both treatment
groups. VERTIGOHEEL(R) and betahistine were therapeutically equivalent in
reducing the duration and intensity of vertigo attacks. Although not clinically
significant, VERTIGOHEEL(R) was marginally superior to betahistine in reducing
the frequency of vertigo attacks.
The study's secondary efficacy variables involved quality of life
measurements, including physical health and mental activity, from the patients'
point of view. These were assessed using the standardized MOS-SF36 validated
quality of life questionnaire as well as a four-part vertigo-specific
questionnaire. The patients' and investigators' global assessment of efficacy
also comprised the study's secondary efficacy variables. 
There was an increase in the patients' quality of life and a significant
decrease in vertigo-specific symptoms in both treatment groups.
According to investigators, more than 70 percent of patients in both of the
VERTIGOHEEL(R) and betahistine groups reported a significant
improvement in quality of life. In addition, for more than 90 percent of study
patients in both treatment groups, the tolerability of both drugs was rated as
"good" or "excellent."
Clinical laboratory data and vital signs for each patient remained
essentially unchanged throughout the course of the study, indicating a
favorable safety profile for both VERTIGOHEEL(R) and betahistine.
"These results establish VERTIGOHEEL(R) as a safe and effective
treatment for vertigo," said study investigator Michael Weiser, PhD,
Director of Clinical Research, Heel, GmbH. "VERTIGOHEEL(R) was shown to be as
effective as betahistine, a standard anti-vertigo drug, in significantly
reducing the frequency and severity of vertigo attacks, and was also very
well-tolerated. Because of the lack of effective conventional treatments,
VERTIGOHEEL(R) fills a serious void for treating millions of Americans
suffering from vertigo and other types of dizziness." 
"We are excited about the publication of this head-to-head clinical
comparison in an American Medical Association (AMA) journal," said Perry
Pedersen, Vice President, General Manager, Heel Inc., the U.S.
manufacturer and exclusive distributor of VERTIGOHEEL(R). "Not only does it
prove that VERTIGOHEEL(R) is an effective and safe drug for treating vertigo,
but it also demonstrates why homeopathic drugs are gaining acceptance among
patients and medical practitioners throughout the world. The fact that such a
study has been published in an AMA journal is a landmark in itself. The
clinical utility of homeopathic drugs like VERTIGOHEEL(R) is now being
objectively assessed by our most respected medical institutions."
About Vertigo
Vertigo is a condition where sufferers experience a false sensation of
motion - either horizontally or vertically. It is a disorder of the
body's vestibular system, which is located in the inner ear and
responsible for maintaining equilibrium. Although manyof the causes of vertigo
are unknown, the most common causes include head trauma or whiplash, migraine,
advanced age, ear infections, viruses, high doses or long-term use of certain
antibiotics, stress and fatigue, and stroke or conditions resulting in reduced
blood flow to the inner ear or brain. Vestibular disorders, which also include
motion sicknesses (e.g., car sickness and sea sickness), are among the most
common reasons for doctor visits, with U.S. physicians reporting more than five
million related visits per year.
About Heel Inc.
VERTIGOHEEL(R) is manufactured and distributed in the U.S. by Heel Inc., a
marketer and manufacturer of combination homeopathic remedies based in
Albuquerque, NM. Heel Inc. is also the U.S. distributor for its parent company,
Heel GmbH in Baden-Baden, Germany, the world's largest manufacturer and
marketer of combination homeopathic pharmaceuticals, distributing products in
over 55 countries. Heel Inc. manufactures and markets over-the-counter (OTC)
and prescription pharmaceuticals (including injectables) according to the
regulatory requirements for homeopathic drugs as defined in the 1938 Food, Drug
and Cosmetic Act, the FDA's 1988 Compliance Policy Guides - Conditions Under
Which Homeopathic Drugs May be Marketed, the Homeopathic Pharmacopoeia
Convention of United States (HPCUS), and local health agencies (e.g., the New
Mexico State Board of Pharmacy). 
Unlike classical homeopathic drugs, the active ingredients in products
such as VERTIGOHEEL(R) are not ultra-highly diluted and the
pharmacological and clinical profiles can be defined within the
conventional medical paradigm. The products of Heel Inc. represent a
bridge between classical homeopathy and conventional pharmacology.
For full prescribing information about VERTIGOHEEL (R), please see page 1187 of
the 1998 Physicians' Desk Reference.
CONTACT: Heel Inc.
Perry Pedersen, 505/293-3843
or MCS Public Relations
Olga Silva, 908/273-9626